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Trial registered on ANZCTR


Registration number
ACTRN12625000106437
Ethics application status
Approved
Date submitted
6/12/2024
Date registered
30/01/2025
Date last updated
30/01/2025
Date data sharing statement initially provided
30/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Do smart inhalers improve medication adherence and reduce asthma exacerbations for children aged 5-9 years?: A Randomised Controlled Trial
Scientific title
Effect of addressing medication adherence using FindAir smart devices and FindAir Asthma Diary App on the incidence of asthma exacerbations in children aged 5-9 years: A Randomised Controlled Trial
Secondary ID [1] 312934 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood asthma 335099 0
Condition category
Condition code
Respiratory 331601 331601 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Child and parent/guardian dyads will attend a one-off 45 to 60-minute face-to-face consultation with a Research Assistant at the Hunter Medical Research Institute. The Research Assistant will provide dyads with a pair of FindAir smart inhaler devices (one for their preventer inhaler and one for their reliever inhaler) which attach to the top of the child's usual asthma inhalers. The FindAir smart devices are an add-on to conventional preventer/reliever inhaler devices. Conventional inhaler devices generally have a dose counter which indicates the number of doses of medication remaining in the inhaler. In contrast, the FindAir smart devices automatically record every time the asthma inhalers are used, including the time of use and number of doses taken. The Research Assistant will assist dyads in the intervention group to install and set up the FindAir Asthma Diary App on their smart device and provide education in how to use the devices and the App. The FindAir smart devices connect via blue tooth to the FindAir Diary App. After setup, the App provides automatic alerts/reminders on the smart device when the child is due to take their inhaler, provides visual feedback on adherence to preventer medication and asthma control based on the child's use of their reliever medication, and indicates the date on which each inhaler will need to be replaced. With parental consent, the FindAir Diary App will also be setup to allow the research team and the child's General Practitioner (GP) to view the child's inhaler use data via unique access codes, accessed via a web-based platform. The research team will contact the child's GP to provide details about how to access and use the GP FindAir Platform to view their patient's inhaler use data. GPs or their nominated practice nurse/manager will be asked to monitor their patient's inhaler use data on a monthly basis to assess asthma care flags (i.e. a continuing pattern of non-adherence to the preventer medication schedule outlined in the child’s Asthma Control Plan or increased reliever bronchodilator use lasting 2 or more days in a row). Where a care flag is identified, the child’s GP may request an appointment with the child and their parent/carer if appropriate. The research team will also undertake monthly monitoring of the child's inhaler use to assess asthma care flags. If a care flag related to a pattern of non-adherence with asthma preventer medication is detected, the research team will notify parents via SMS (more than 2 days of preventer medication in a row missed) or phone call (more than 4 days of preventer medication in a row missed). The notification will inform parents that the smart device data is showing that their child has missed using their preventer medication for more than 2/4 days in a row, and reinforce that regular use of the preventer is important for helping to reduce asthma symptoms and keeping their child feeling well. If a care flag related to poor asthma control is detected (i.e. use of their reliever medication for 2 or more days in a row and occurring 4 or more times during a one-month period), the research team will notify parents via phone call, with a recommendation that they may wish to make an appointment for their child with their GP. With GP consent, the research team will also notify GPs in the case of a care flag related to poor asthma control, with a recommendation that the GP schedule an appointment with their patient if appropriate. The Research Assistant will also phone parents at 2 weeks and 3 months after the baseline survey and device/App set up meeting to respond to any questions or issues dyads might have encountered. In addition, the Research Assistant will phone parent/guardians if the FindAir data indicates that the smart devices are not connected to child’s preventer and reliever inhalers for 5 or more days in a row during the intervention period and assist parent/guardians to reconnect the devices if necessary. The total duration of involvement in the study is 14 months, with the FindAir devices estimated to have a (non-replaceable) battery life of 12 months.
Intervention code [1] 329465 0
Treatment: Devices
Comparator / control treatment
Child and parent/guardian dyads in the control condition will continue to receive usual GP care. In addition, dyads will attend a one-off 45 to 60-minute face-to- face consultation with a Research Assistant at the Hunter Medical Research Institute. The Research Assistant will provide dyads with a set of FindAir smart preventer and reliever inhaler devices which attach to the top of the child's usual asthma inhalers. Receipt of the smart devices for the control group is solely to enable collection of data about the child’s inhaler use. Other functions of the smart inhaler (e.g. medication reminders, feedback on adherence and asthma control) will not be accessible to participants in the control group. This will be facilitated by parents/guardians downloading the FindAir Researcher App on their smart device. Control group parents will be asked to allow the research team to access their child's smart inhaler use data via an access code. The Research Assistant will phone parent/guardians if the FindAir data indicates that the smart devices are not connected to child’s preventer and reliever inhalers for 5 or more days in a row during the intervention period and assist parent/guardians to reconnect the devices if necessary. The total duration of involvement in the study is 14 months, with the FindAir devices estimated to have a (non-replaceable) battery life of 12 months. At the conclusion of the 14 month study, control group dyads will be offered a preventer inhaler smart device and assistance to set up the device and FindAir Diary App for use over the following 12 months.
Control group
Active

Outcomes
Primary outcome [1] 339339 0
Number of severe asthma exacerbations in a 12-month period.
Timepoint [1] 339339 0
Baseline, every 4 weeks during the 12 month trial period, and at 14 months (2 months post-completion of the trial period). The primary timepoint is 12 months post-baseline (at completion of the trial period).
Primary outcome [2] 340358 0
Number of moderate asthma exacerbations in a 12-month period.
Timepoint [2] 340358 0
Baseline, every 4 weeks during the 12 month trial period, and at 14 months (2 months post-completion of the trial period). The primary timepoint is 12 months post-baseline (at completion of the trial period).
Secondary outcome [1] 439576 0
Adherence to preventer therapy.
Timepoint [1] 439576 0
Data will be extracted at 12 months post-baseline for the preceding 12-month period, and at 14 months post-baseline for the preceding 2-month period.
Secondary outcome [2] 439577 0
Use of reliever therapy.
Timepoint [2] 439577 0
Data will be extracted at 12 months post-baseline for the preceding 12-month period, and at 14 months post-baseline for the preceding 2-month period.
Secondary outcome [3] 439578 0
Self-reported asthma symptom control.
Timepoint [3] 439578 0
Baseline, every 4 weeks during the 12 month trial period, and at 14 months (2 months post-completion of the trial period).
Secondary outcome [4] 439579 0
GP visits related to asthma exacerbations.
Timepoint [4] 439579 0
Baseline, every 3 months during the 12 month trial period and at 14 months (2 months post-completion of the trial period)
Secondary outcome [5] 439580 0
Self-reported adherence to preventer therapy.
Timepoint [5] 439580 0
Baseline, every 3 months during the 12 month trial period and at 14 months (2 months post-completion of the trial period)
Secondary outcome [6] 439581 0
Number of inpatient hospital stays related to asthma.
Timepoint [6] 439581 0
Data will be extracted at 12 months post-baseline for the preceding 12-month period, and at 14 months post-baseline for the preceding 2-month period.
Secondary outcome [7] 442596 0
Health related quality of life.
Timepoint [7] 442596 0
Baseline, 6 and 12 months post commencement of the intervention, and 14 months (2 months post-completion of the trial period).
Secondary outcome [8] 443833 0
Specialist visits related to asthma exacerbations.
Timepoint [8] 443833 0
Baseline, every 3 months during the 12 month trial period and at 14 months (2 months post-completion of the trial period)
Secondary outcome [9] 443837 0
Length of inpatient hospital stay related to asthma.
Timepoint [9] 443837 0
Data will be extracted at 12 months post-baseline for the preceding 12-month period, and at 14 months post-baseline for the preceding 2-month period.
Secondary outcome [10] 443838 0
Number of hospital intensive care unit stays related to asthma.
Timepoint [10] 443838 0
Data will be extracted at 12 months post-baseline for the preceding 12-month period, and at 14 months post-baseline for the preceding 2-month period.
Secondary outcome [11] 443839 0
Number of asthma medication changes.
Timepoint [11] 443839 0
Data will be extracted at 12 months post-baseline for the preceding 12-month period, and at 14 months post-baseline for the preceding 2-month period.
Secondary outcome [12] 443842 0
Number of specialist referrals related to asthma.
Timepoint [12] 443842 0
Data will be extracted at 12 months post-baseline for the preceding 12-month period, and at 14 months post-baseline for the preceding 2-month period.
Secondary outcome [13] 443843 0
Number of emergency department visits related to an asthma exacerbation.
Timepoint [13] 443843 0
Data will be extracted at 12 months post-baseline for the preceding 12-month period, and at 14 months post-baseline for the preceding 2-month period.

Eligibility
Key inclusion criteria
Child and parent/guardians will be eligible if the child:
a) is aged 5-9 years of age;
b) has an asthma diagnosis;
c) resides in the footprint of the Hunter New England Local Health District (HNELHD);
d) has been prescribed any type of inhaled preventer medication, has been prescribed at least one course of oral corticosteroids in the past 12 months OR has had a hospital admission for asthma in the previous 12 months;
e) uses pressurised metered-dose inhaler (pMDI) devices and
f) has a usual GP or attends a usual GP practice.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
N/A

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes (randomisation conducted by an independent researcher not involved in recruitment).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary outcome will be compared between groups at the follow-up time point (number of exacerbations in the previous 12 months) using a mixed effects negative binomial regression model. The model will include fixed categorical effects for time, treatment arm and the interaction between the two. The model will include random intercepts at the participant level to model the repeated outcome measurements. Rate ratios and 95% confidence intervals will be presented at each time point, as well as standardised mean differences. Adherence will be compared between groups using a chi-square test, asthma symptom control will be compared between groups using a linear mixed effects regression model. The feasibility and suitability of the PedsQL will also be explored as a potential health economics outcome measure.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/02/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/08/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27376 0
John Hunter Children's Hospital - New Lambton
Recruitment postcode(s) [1] 43474 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 317368 0
Charities/Societies/Foundations
Name [1] 317368 0
Asthma Australia
Country [1] 317368 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 319657 0
None
Name [1] 319657 0
Address [1] 319657 0
Country [1] 319657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316098 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 316098 0
https://www.hnehealth.nsw.gov.au/research-office/research_ethics
Ethics committee country [1] 316098 0
Australia
Date submitted for ethics approval [1] 316098 0
29/03/2024
Approval date [1] 316098 0
24/04/2024
Ethics approval number [1] 316098 0
2024/ETH00631

Summary
Brief summary
The primary aim of this pilot randomised controlled trial is to examine if smart inhaler use as part of asthma care for children aged 5-9 years is effective in reducing moderate and severe exacerbations over a 12 month period. The secondary aims of the research are to: i) increase children’s adherence to preventer therapy; ii) decrease use of reliever therapy; iii) increase self-reported asthma control; and iv) decrease healthcare use reacted to asthma (GP and specialist visits, ED presentations and hospital admissions). The feasibility and the acceptability of the intervention will also be examined. A total of 40 children aged 5-9 years with asthma along with one parent/carer will be recruited. Each child- parent dyad will be randomly allocated to the intervention (n=20) or usual care condition (n=20). The intervention includes: a) Provision of smart inhaler devices for reliever and preventer inhalers, and education in use; b) FindAir system facilitated prompts and feedback to children/parents (eg daily medication reminders); c) Researcher support in the use of the FindAir smart devices and the FindAir Asthma Diary App; d) FindAir system facilitated feedback to GPs and GP-based nurses; and FindAir facilitated feedback on asthma care flags to parent/carers and GPs (if applicable). The control group will receive usual care. The control group will also receive FindAir smart devices for their child’s preventer and reliever puffers to enable data collection of the child’s inhaler use; the other functions of the smart inhaler (e.g., medication reminders, feedback) will not be accessible to participants in the control group.

Outcome data (number of moderate/ severe exacerbations and preventer adherence) will be collected at baseline, during the 12-month intervention, and 2 months after the intervention in both the intervention and control groups. Intervention feasibility will be determined by examining use of the smart inhaler. Acceptability will be determined via semi- structured interviews with child and parent/guardians in the intervention group and participating clinicians.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136770 0
Prof Joerg Mattes
Address 136770 0
Department of Paediatric Respiratory & Sleep Medicine, John Hunter Children's Hospital Locked Bag 1, Newcastle NSW 2305
Country 136770 0
Australia
Phone 136770 0
+61240420209
Fax 136770 0
Email 136770 0
[email protected]
Contact person for public queries
Name 136771 0
Dr Megan Freund
Address 136771 0
Health Behaviour Research Collaborative, L4W, HMRI Building, University Drive Callaghan, NSW 2308
Country 136771 0
Australia
Phone 136771 0
+61240420834
Fax 136771 0
Email 136771 0
[email protected]
Contact person for scientific queries
Name 136772 0
Dr Megan Freund
Address 136772 0
Health Behaviour Research Collaborative, L4W, HMRI Building, University Drive Callaghan, NSW 2308
Country 136772 0
Australia
Phone 136772 0
+61240420834
Fax 136772 0
Email 136772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.